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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K921388
Device Name BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
Applicant
Biochem International, Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53186
Applicant Contact DAVID UHEN
Correspondent
Biochem International, Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53186
Correspondent Contact DAVID UHEN
Regulation Number870.1110
Classification Product Code
DSK  
Date Received03/23/1992
Decision Date 05/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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